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Sr. Associate Scientist, Process Development
Company | Gilead Sciences |
Address | La Verne, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-09-04 |
Posted at | 8 months ago |
For Current Gilead Employees And Contractors
- Contributes to and leads complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
- May supervise personnel, including organizing and prioritizing daily tasks, and performing training.
- Designs experiments and ensures they accomplish goals.
- Analyzes and identifies risks with processes, technologies, and methods, creates a working plan to prevent potential issues.
- Identifies and introduces new technology and/or methods to the organization, and trains junior staff on their implementation.
- Revises, improves, or develops new methods to support commercial products; writes protocols and reports.
- Assists with bench experiments to support collaborations with external researchers.
- Contributes to and leads technical investigations of process deviations, and assessment of their impact on product quality. Defines requirements for, and reviews master batch records.
- Liaises with manufacturing groups to deliver new and improved drug products and processes.
- Contributes to user requirement specification and provides expert process technical support to utilize and validate new and improved technologies.
- Leads technical support activities related to maintaining commercial product supplies through management of internal and external resources.
- Can lead one or more specific components of departmental strategic initiatives.
- Identifies opportunities to improve processes within the business and provides technical expertise and support to process improvement efforts.
- High degree of technical competence and effective communication skills, both oral and written.
- Strong interpersonal and communication skills, verbal and written.
- Excellent troubleshooting skills and ability to solve complex technical issues.
- Able to identify data or analytical issues and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
- Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
- Experience with statistical data analysis tools is preferred.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- Knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
- Strong project management and organizational skills.
- BS in Biology, Chemistry or Physics and 6+ years of experience; or MS degree and 4+ years of experience.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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